Different Dosage of Decompression Therapy on Symptoms of Lumbar Radiculopathy

NCT ID: NCT04852900

Last Updated: 2021-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-14

Study Completion Date

2021-07-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will provide evidence about how much dose of decompression more effective for the treatment of lumbar radiculopathy. As this hypothesis has no evidence about the dosage of decompression in literature till now.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Decompression therapy differs from traction-based therapy in that the traction applied to the spine in decompression therapy is typically alternated between lower and higher levels of tension for predetermined periods of time. In either therapy, spinal tension is maintained for the period's typically extending 30-minutes or longer. This study will provide evidence about how much dose of decompression more effective for the treatment of lumbar radiculopathy. As this hypothesis has no evidence about the dosage of decompression in literature till now.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lumbar Radiculopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Decompression with 30%

Decompression with 30% and mobilization

Group Type EXPERIMENTAL

Decompression with 30%

Intervention Type OTHER

* Hot Pack for 10 mins Soft Tissue Mobilization
* Muscle Strengthening
* Decompression with 30% The total time for the session will be 45 minutes and there will be 03 sessions/week for 6 weeks

Decompression with 40%

Decompression with 40% and mobilization

Group Type EXPERIMENTAL

Decompression with 40%

Intervention Type OTHER

* Hot Pack for 10 mins Soft Tissue Mobilization
* Muscle Strengthening
* Decompression with 30% The total time for the session will be 45 minutes and there will be 03 sessions/week for 6 weeks

Decompression with 50%

Decompression with 50% and mobilization

Group Type EXPERIMENTAL

Decompression with 50%

Intervention Type OTHER

* Hot Pack for 10 mins Soft Tissue Mobilization
* Muscle Strengthening
* Decompression with 30% The total time for the session will be 45 minutes and there will be 03 sessions/week for 6 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Decompression with 30%

* Hot Pack for 10 mins Soft Tissue Mobilization
* Muscle Strengthening
* Decompression with 30% The total time for the session will be 45 minutes and there will be 03 sessions/week for 6 weeks

Intervention Type OTHER

Decompression with 40%

* Hot Pack for 10 mins Soft Tissue Mobilization
* Muscle Strengthening
* Decompression with 30% The total time for the session will be 45 minutes and there will be 03 sessions/week for 6 weeks

Intervention Type OTHER

Decompression with 50%

* Hot Pack for 10 mins Soft Tissue Mobilization
* Muscle Strengthening
* Decompression with 30% The total time for the session will be 45 minutes and there will be 03 sessions/week for 6 weeks

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Both Genders
* Age between 30 to 50 years
* Unilateral Radiculopathy
* Limited SLR (Less than 60 degree)
* Pain on Numeric Pain Rating Scale \< 7
* BMI ≤ 30

Exclusion Criteria

* Severe paraspinal Muscle Spasm
* Acute prolapse intervertebral disc
* Bilateral Positive SLR
* Osteoporotic
* H/O Spinal Fracture
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riphah International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nazish Rafique, MSPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Max spine rehab centre, G8 markaz

Islamabad, Punjab Province, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

Alexander CE, Weisbrod LJ, Varacallo MA. Lumbosacral Radiculopathy. 2024 Feb 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK430837/

Reference Type BACKGROUND
PMID: 28613587 (View on PubMed)

Berry JA, Elia C, Saini HS, Miulli DE. A Review of Lumbar Radiculopathy, Diagnosis, and Treatment. Cureus. 2019 Oct 17;11(10):e5934. doi: 10.7759/cureus.5934.

Reference Type BACKGROUND
PMID: 31788391 (View on PubMed)

Chen BL, Guo JB, Zhang HW, Zhang YJ, Zhu Y, Zhang J, Hu HY, Zheng YL, Wang XQ. Surgical versus non-operative treatment for lumbar disc herniation: a systematic review and meta-analysis. Clin Rehabil. 2018 Feb;32(2):146-160. doi: 10.1177/0269215517719952. Epub 2017 Jul 17.

Reference Type BACKGROUND
PMID: 28715939 (View on PubMed)

Shin JS, Lee J, Lee YJ, Kim MR, Ahn YJ, Park KB, Shin BC, Lee MS, Ha IH. Long-Term Course of Alternative and Integrative Therapy for Lumbar Disc Herniation and Risk Factors for Surgery: A Prospective Observational 5-Year Follow-Up Study. Spine (Phila Pa 1976). 2016 Aug 15;41(16):E955-E963. doi: 10.1097/BRS.0000000000001494.

Reference Type BACKGROUND
PMID: 26882505 (View on PubMed)

Schoenfeld AJ, Laughlin M, Bader JO, Bono CM. Characterization of the incidence and risk factors for the development of lumbar radiculopathy. J Spinal Disord Tech. 2012 May;25(3):163-7. doi: 10.1097/BSD.0b013e3182146e55.

Reference Type BACKGROUND
PMID: 22543563 (View on PubMed)

Abdurrahman G, Şener Ü, Karabacak H, Kağan Ü. Kadın ve erkek genç erişkinler arasında fiziksel aktivite ve yaşam kalitesi farklılıklarının araştırılması. Kocatepe Tıp Dergisi. 2011;12(3):145-50.

Reference Type BACKGROUND

Demirel A, Yorubulut M, Ergun N. Regression of lumbar disc herniation by physiotherapy. Does non-surgical spinal decompression therapy make a difference? Double-blind randomized controlled trial. J Back Musculoskelet Rehabil. 2017 Sep 22;30(5):1015-1022. doi: 10.3233/BMR-169581.

Reference Type BACKGROUND
PMID: 28505956 (View on PubMed)

Oh H-J, Jeon C-B, Jeong M-G, Choi S-J. The effects of spinal decompression therapy on pain and disability in patients with chronic low back pain. The Journal of Korean Physical Therapy. 2017;29(6):299-302.

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC/00856 Iqra Hamid

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.